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Validation study of effects on brain function by test-food intake in a single dose

Validation study of effects on brain function by test-food intake in a single dose - Validation study of effects on brain function by test-food intake in a single dose

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000051211
Enrollment
30
Registered
2024-06-06
Start date
2023-06-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy male/female adults

Interventions

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy male/female subjects ranging in age from 20 to 34, at informed consent. (2) Subjects having less than 25.0 kg/m2 of BMI. (3) Subjects with no smoking (not less than one year). (4) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.

Exclusion criteria

Exclusion criteria: (1) Subjects being under some kind of continuous medical treatment, including the study period. (2) Subjects who have periodically used health-specific / functional (e.g., gamma-aminobutyric acid, L. gasseri CP2305)/ health foods including supplements, which might affect the autonomic nervous system, stress, fatigue and brain function. (3) Subjects with incompatible chest (e.g., thick bodyhair, pacemaker-fitting) for heartbeat measurements. (4) Subjects with excessive alcohol intake. (5) Subjects with extremely irregular eating habits, and subjects having an irregular life rhythm with irregular shift work or midnight one. (6) Subjects who are under other clinical tests with some kind of medicine/food, or participated in those within four weeks before this study, or are planning to join those after the consent. (7) Subjects who are under a large stress condition with some kind of life event, such as house-moving, transfer, bereavement, etc., within three months before the agreement for this study and during the study period. (8) Subjects with any difficulty in giving up drinking since the day before the scheduled date of this study. (9) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (10) Subjects getting excessive exercise every day. (11) Subjects with a serious symptom of premenstrual syndrome. (12) Pregnant, possibly pregnant, and lactating women. (13) Subjects having some kind of drug and/or food allergy. (14) Subjects who break out in a rash from putting electrodes on the head and chest. (15) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.

Design outcomes

Primary

MeasureTime frame
Cognitrax (symbol-digit coding, stroop, and shifting attention)

Secondary

MeasureTime frame
1. The Profile of Mood States Second Edition (Japanese short ver.) 2. Psychological questionnaire 3. Heartbeat

Countries

Japan

Contacts

Public ContactMasanori Numa

CPCC Company Limited Clinical Planning Department

cpcc-contact@cpcc.co.jp03-6225-9001

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026